The individual who appears is for illustrative purposes. The person depicted is a model and not a real patient.
In pediatric patients…VARIBAR® (barium sulfate) can help maximize the benefit/risk ratio of MBSS.
The Smallest Patients Are at Greatest Risk From Radiation Exposure During MBSS.1,2
Radiation-related cancer risks are much higher for pediatric patients than older adults for two main reasons:
- Developing cells are more sensitive to radiation exposure1
- Children’s longer life expectancy increases the likelihood of developing radiation-related cancer1
In a study, female infants exposed to 100 mGy of X-rays were found to have a cancer risk of 634 per 100,000 versus 115 for male infants and four for 50-year-old women.1
VARIBAR® (barium sulfate) Can Help Maximize the Benefit/Risk Ratio of MBSS.
Research shows that standardization of MBSS (also known as VFSS) protocols optimizes the ability to capture swallowing impairment and minimizes radiation exposure, leading to safer MBSS examinations.3 With standardized viscosities, VARIBAR® (barium sulfate) is the only FDA-approved barium sulfate contrast product line for adults and pediatric patients for evaluating swallowing using MBSS.4-8
Smaller Bodies May Require Greater Magnification—and Exposure.1,3
The individuals who appear are for illustrative purposes. All persons depicted are models and not real patients or healthcare professionals.
The size of structures being imaged in young children is smaller and often requires magnification, with increased radiation exposure.1 They also have more soft tissue versus adult ossified cartilage so they may require a different beam quality and/or filtration to allow for sufficient image contrast. Using a standardized method for conducting an MBSS can help minimize time and radiation exposure.3
As Low As Reasonably Achievable…
Although the radiation dose from MBSS is relatively low, any radiation from medical tests must be minimized to comply with the “As Low As Reasonably Achievable” principle.2
This is particularly true in the pediatric population, especially infants. Since adverse effects of radiation exposure are known to be age-dependent, children are more sensitive to radiation-induced cancer than are adults. The risk of developing a radiation-related cancer is higher for a young child compared to an adult exposed to an identical radiation dose.9
The individual who appears is for illustrative purposes. The person depicted is a model and not a real patient.
For All Ages
VARIBAR THIN LIQUID, NECTAR, and THIN HONEY formulations are indicated for pediatric patients.4-6
For Pediatric Patients 6 Months and Older
VARIBAR HONEY and PUDDING are indicated for baby-food ready pediatric patients.7,8
The individuals who appear are for illustrative purposes. All persons depicted are models and not real patients.
Resources and Professional Education
Martin-Harris B, et al.
INDICATIONS AND USAGE | IMPORTANT SAFETY INFORMATION
VARIBAR® (barium sulfate)
IMPORTANT SAFETY INFORMATION:
For Oral Administration. This product should not be used in patients with known or suspected perforation of the GI tract, known obstruction of the GI tract, high risk of aspiration, or hypersensitivity to barium sulfate products. Rarely, severe allergic reactions of anaphylactoid nature have been reported following administration of barium sulfate contrast agents. Aspiration may occur during the modified barium swallow examination, monitor the patient for aspiration.
INDICATIONS AND USAGE | IMPORTANT SAFETY INFORMATION
VARIBAR® (barium sulfate)
INDICATIONS
VARIBAR® THIN HONEY (barium sulfate) oral suspension, VARIBAR® NECTAR (barium sulfate) oral suspension, and VARIBAR® THIN LIQUID (barium sulfate) oral suspension are radiographic contrast agents indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients.
VARIBAR® HONEY (barium sulfate) oral suspension and VARIBAR® PUDDING (barium sulfate) oral paste are radiographic contrast agents indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
These products should not be used in patients with known or suspected perforation of the gastrointestinal (GI) tract; known obstruction of the GI tract; high risk of GI perforation such as those with a recent GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, post GI surgery or biopsy, acute GI injury or burn, or recent radiotherapy to the pelvis; high risk of aspiration such as those with known or suspected tracheo-esophageal fistula or obtundation; known severe hypersensitivity to barium sulfate or any of the excipients of the product used.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Barium sulfate preparations contain a number of excipients, including natural and artificial flavors, and may induce serious hypersensitivity reactions. The manifestations include hypotension, bronchospasm and other respiratory impairments, and dermal reactions including rashes, urticaria, and itching. A history of bronchial asthma, atopy, food allergies, or a previous reaction to a contrast agent may increase the risk for hypersensitivity reactions. Emergency equipment and trained personnel should be immediately available for treatment of a hypersensitivity reaction.
Intra-abdominal Barium Leakage
The use of VARIBAR PRODUCTS is contraindicated in patients at high risk of perforation of the GI tract. Administration of VARIBAR PRODUCTS may result in leakage of barium from the GI tract in the presence of conditions such as carcinomas, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, or diverticulitis, and in patients with a severe stenosis at any level of the GI tract, especially if it is distal to the stomach. The barium leakage has been associated with peritonitis and granuloma formation.
Delayed Gastrointestinal Transit and Obstruction
Orally administered barium sulfate may accumulate proximal to a constricting lesion of the colon, causing obstruction or impaction with development of baroliths (inspissated barium associated with feces) and may lead to abdominal pain, appendicitis, bowel obstruction, or rarely perforation. Patients with the following conditions are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired GI motility, electrolyte imbalance, dehydration, on a low residue diet, taking medications that delay GI motility, constipation, pediatric patients with cystic fibrosis or Hirschsprung disease, and the elderly. To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration after the barium sulfate procedure. When administering VARIBAR PUDDING, consider the administration of laxatives.
Aspiration Pneumonitis
The use of VARIBAR PRODUCTS is contraindicated in patients with trachea-esophageal fistula. Oral administration of barium is associated with aspiration pneumonitis, especially in patients with a history of food aspiration or with compromised swallowing mechanism. Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. In patients at risk for aspiration, begin the procedure with a small ingested volume of VARIBAR PRODUCTS. Monitor the patient closely for aspiration, discontinue administration of VARIBAR PRODUCTS if aspiration is suspected, and monitor for development of aspiration pneumonitis.
Systemic Embolization
Barium sulfate products may occasionally intravasate into the venous drainage of the GI tract and enter the circulation as a "barium embolus" leading to potentially fatal complications which include systemic and pulmonary embolism, disseminated intravascular coagulation, septicemia and prolonged severe hypotension. Although this complication is exceedingly uncommon after oral administration of a barium sulfate suspension, monitor patients for potential intravasation when administering barium sulfate.
ADVERSE REACTIONS
The most common adverse reactions are nausea, vomiting, diarrhea, and abdominal cramping. Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for full Prescribing Information for VARIBAR® THIN LIQUID (barium sulfate) oral suspension.
Please click here for full Prescribing Information for VARIBAR® THIN HONEY (barium sulfate) oral suspension.
Please click here for full Prescribing Information for VARIBAR® NECTAR (barium sulfate) oral suspension.
Please click here for full Prescribing Information for VARIBAR® HONEY (barium sulfate) oral suspension.
Please click here for full Prescribing Information for VARIBAR® PUDDING (barium sulfate) oral paste.
VARIBAR is manufactured by E-Z-EM Canada Inc., for E-Z-EM, Inc., a subsidiary of Bracco Diagnostics Inc., Princeton, NJ 08540.
VARIBAR is a registered trademark of E-Z-EM, Inc.
References:
1. McGhee K. Making an important pediatric diagnostic test easier to swallow. Medical University of South Carolina. April 20, 2020. https://web.musc.edu/about/news-center/2020/04/20/bonilha-swallow-study.
2. Strauss KJ, Kaste, SC. The ALARA (as low as reasonably achievable) concept in pediatric interventional and fluoroscopic Imaging: Striving to keep radiation doses as low as possible during fluoroscopy of pediatric Patients—a white paper executive summary. Pediatr Radiol. 2006 Sep;36(Suppl 2):110-112. https://pubmed.ncbi.nlm.nih.gov/17412149/.
3. Steele CM, Martin-Harris B, Gosa M, Edwards Allen S. Diagnosis and Management of Swallowing Physiology: Standardized Contrast, the MBSImP™ & the IDDSI Framework. Appl Radiol. https://appliedradiology.com/articles/diagnosis-and-management-of-swallowing-physiology-standardized-contrast-the-mbsimp-the-iddsi-framework.
4. VARIBAR® THIN LIQUID (barium sulfate) for oral suspension full Prescribing Information. Princeton, NJ: Bracco Diagnostics Inc.; April 2023.
5. VARIBAR® NECTAR (barium sulfate) oral suspension full Prescribing Information. Princeton, NJ: Bracco Diagnostics Inc.; August 2024.
6. VARIBAR® THIN HONEY (barium sulfate) oral suspension full Prescribing Information. Princeton, NJ: Bracco Diagnostics Inc.; August 2024.
7. VARIBAR® HONEY (barium sulfate) oral suspension full Prescribing Information. Princeton, NJ: Bracco Diagnostics Inc.; August 2024.
8. VARIBAR® PUDDING (barium sulfate) oral paste full Prescribing Information. Princeton, NJ: Bracco Diagnostics Inc.; August 2024.
9. Radiation Risks and Pediatric Computed Tomography (CT): A Guide for Health Care Providers. National Cancer Institute. Sept 2018. https://www.cancer.gov/about-cancer/causes-prevention/risk/radiation/pediatric-ct-scans.
INDICATIONS AND USAGE | IMPORTANT SAFETY INFORMATION
VARIBAR® (barium sulfate)
IMPORTANT SAFETY INFORMATION:
For Oral Administration. This product should not be used in patients with known or suspected perforation of the GI tract, known obstruction of the GI tract, high risk of aspiration, or hypersensitivity to barium sulfate products. Rarely, severe allergic reactions of anaphylactoid nature have been reported following administration of barium sulfate contrast agents. Aspiration may occur during the modified barium swallow examination, monitor the patient for aspiration.